1. Field of the Invention
The present invention relates to novel ingestible amine functionalized and cross-linked homopolymers which are useful as adsorbents for bile salts. Note particularly, the invention is directed toward the treatment of hypercholesterolemia by removing through adsorption of the bile acids and sales from the small intestine, thereby increasing the catabolism of cholesterol in the liver with a concomitant decrease in the blood cholesterol level.
2. Related Art
All available evidence indicates that the incidence of higher than normal blood serum cholesterol levels in humans is associated with atheroslerosis and other hypercholesterolemic disease signs. Hypercholesterolemia, the leading cause of death in many countries, is presently treated by restricted and special dietary intake, inhibitation of cholesterol synthesis, accelerated catabolism and prevention of gastrointestinal adsorption. Increased catabolism of cholesterol can be achieved by the oral administration of bile salt binding agents, which has been widely used and well accepted.
Applicants have already described, in the aforementioned patent application, bile salt adsorbents which consist of amine functionalized homopolymers having a hydrophilic, cross-linked and non-digestible homopolymer backbone. These adsorbents are more hydrophilic than cholestyramine, the most widely used adsorbent for bile salts, and thus have better biocompatibility.
As discussed in the above patent application, for any medical applications, especially by oral administration, the hydrophilicity or water-swellability of a polymer material to be administrated is often considered as a major evaluation parameter because most of the human fluids have high water contents. Generally, the more water-swellable the polymer material is, the more biocompatible it will be.